Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241555 FDA 510(k)
- FDA Product Code
- MQV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3045 FDA 510(k)
- Regulation Number
- 888.3045 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC is an implant intended to fill bony voids or gaps of the skeletal system, including extremities and pelvis. These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
The device is supplied by RTI Surgical, Inc. and has received FDA 510(k) clearance under K241555. It is regulated under 21 CFR 888.3045 and was cleared via a traditional 510(k) pathway with a decision date of February 21, 2025.
Frequently asked questions
What is the Moldable Bone Void Filler and Moldable Bone Void Filler + CCC used for?
This implant is intended to fill bony voids or gaps in the skeletal system, including extremities and pelvis, that are surgically created or result from traumatic injury and are not intrinsic to bony stability.
How is the Moldable Bone Void Filler and Moldable Bone Void Filler + CCC supplied and is it sterile?
The device is supplied by RTI Surgical, Inc. and is provided in a sterile condition as part of its implant design for surgical use.
Is the Moldable Bone Void Filler and Moldable Bone Void Filler + CCC single-use or reusable?
As an implant intended for surgical placement to fill bony defects, the device is designed for single-use only and should not be reused after implantation.
What regulatory pathway was used for the Moldable Bone Void Filler and Moldable Bone Void Filler + CCC?
The device received FDA 510(k) clearance under K241555 through a traditional 510(k) pathway, with a decision date of February 21, 2025, and is regulated under 21 CFR 888.3045.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Moldable Bone Void Filler and Moldable Bone Void Filler + CCC by RTI ..., Moldable Bone Void Filler and Moldable Bone Void Filler + CCC, PDF February 21, 2025 Ellen Rounds 11621 Research Circle Regulation Number ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241555 | Class II | Active |
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Manufacturer
- Manufacturer
- Rti Surgical, Inc.
Sources (1)
- FDA 510(k) K241555 24 fields · synced Oct 1, 2026